QA Systems and Validation Specialist
(12 month Contract)
Location: Swords Campus
ABOUT US?
SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to ‘make what matters for a healthy, happier world’, from grams to tonnes. The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs), Highly Potent Active Pharmaceutical Ingredients and Chemical Intermediates for almost 60 years. With a talented workforce, exceptional technical capabilities, and facilities we have made some of the world’s most important medicines and continue to do so. Further information on SK pharmteco can be found at https://vimeo.com/skpharmteco.
Current Need
Cpl in partnership with SK biotek Ireland Quality team are looking for a QA Systems & Validation Specialist for a 12 month contract reporting into the Quality Manager.
Position Description
The QA Systems and Validation Specialist will be responsible for:
• Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.
• Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems.
• Ensure all quality systems are implemented/executed in compliance with ICH Q7, Eudralex, 21 CFR and site Quality standards.
• Provide expertise in the area of validation ensuring compliance with current industry regulations, guidelines and trends. Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Including but not limited to:
• Qualification of premises, equipment and utilities.
• Computer system qualification, CSV.
• Laboratory equipment validation.
• NPI’s
• High level interaction with the various functions on site: Manufacturing, QC, Utilities and Engineering
• Knowledge of relevant process Validation / cleaning Validation / automation is an advantage
• Participate in other projects as directed by the Quality Systems & Validation Manager.
• Strong interpersonal, communication and presentation skills are required for this position as well as good time management, multi-tasking and organisational skills.
Minimum Requirements
• Min of BSc/BEng in Chemistry, Engineering or a science-related discipline with at least 3 years pharmaceutical experience ideally in a QA role. Preferably with experience in change control/documentation management, good manufacturing practices
• Knowledge / appreciation of other site operations such as QC, Operations, Engineering, IT.
• Some experience in Operational Excellence or project management would be desirable.
• Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.